Adeona Announces Initiation of Phase II Clinical Trial of Trimesta™ for Cognitive Dysfunction in Multiple Sclerosis

ANN ARBOR, Mich., Jan. 19, 2012 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (NYSE Amex: AEN), a developer of synthetic DNA-based therapeutics and innovative disease-modifying medicines for serious illnesses, announced today the initiation of the Phase II clinical trial of Trimesta™ (oral estriol) for the treatment of cognitive dysfunction in multiple sclerosis (MS). This clinical trial is intended to enroll 64 relapsing-remitting or secondary-progressive female MS patients at University of California, Los Angeles (UCLA) and is being conducted at by Principal Investigator, Rhonda Voskuhl, M.D., Director, UCLA Multiple Sclerosis Program, Department of Neurology. There is currently no approved therapy for the treatment of cognitive dysfunction in MS.

"We are very excited to initiate patient enrollment in this novel clinical trial of Trimesta in which the primary endpoint is improvement in cognition. Statistics show that 50-65 percent of patients affected by MS will develop disabilities due to a reduction in their cognitive processing speed. Despite the fact that cognitive dysfunction is a primary source of work related disability in MS, there remains no treatment to target this disability," said Dr. Voskuhl, Principal Investigator. "The goal of this trial is to address this unmet need for MS patients, potentially improving a person's mental sharpness and ability to continue working."

This randomized, double-blind, placebo-controlled Phase II clinical trial is based on findings from a previously completed 10-patient, single-agent, crossover Phase I/II clinical trial conducted by Dr. Voskuhl and colleagues at UCLA. The results from the Phase I/II trial demonstrated a statistically significant 14% improvement from baseline in Paced Auditory Serial Addition Test (PASAT) cognitive testing scores in relapsing-remitting MS patients after six months of Trimesta™ therapy (p = 0.04).[i] The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability and is widely used in MS to measure cognitive function. Estriol has also been shown to have neuroprotective benefits in animal models of MS, a property not generally shared by currently approved MS therapies.[ii]

The new Phase II clinical trial is a randomized, double-blind, placebo-controlled trial intended to enroll 64 relapsing-remitting or secondary-progressive female MS patients. Subjects will be equally randomized to receive either once-daily Trimesta™ (oral estriol) or matching placebo. The primary outcome measure is the average change in PASAT scores at 12 months between each group. Secondary outcome measures include relapse rates (the primary endpoint of the ongoing Phase II clinical trial of Trimesta™ for relapsing-remitting MS), whole brain atrophy determined by MRI and safety. Charitable organizations have pledged to financially support a majority of the new MS clinical trial. Detailed information regarding this clinical trial, including contact information for the clinical site, is available at http://www.clinicaltrials.gov/ct2/show/NCT01466114.

In addition to the clinical trial of Trimesta for cognitive dysfunction in MS, Trimesta™ is also the subject of a separate ongoing 15-center Phase II, randomized, double-blind, placebo-controlled clinical trial seeking to demonstrate Trimesta's ability to reduce relapse rates in women with the relapsing-remitting form of MS. With over $8 million in grant funding awarded to date, this separate ongoing Trimesta™ clinical trial should be funded to its completion. Additional information regarding the relapsing-remitting multiple sclerosis clinical trial is available at http://www.clinicaltrials.gov/ct2/show/NCT00451204.

"While our Board of Directors has strategically implemented several actions to prioritize our focus on the emerging field of synthetic biologics, our continued commitment to this important new MS clinical trial, having substantial external funding, is consistent with our mission of maintaining and building value for our shareholders," stated Jeffrey Riley, Adeona's Chairman of the Board.

About Trimesta (oral estriol)

Trimesta™ is Adeona's proprietary drug candidate for the treatment of relapsing-remitting MS and for cognitive dysfunction in MS, both in female patients. Estriol has been approved and marketed for more than 40 years throughout Europe and Asia for the treatment of post-menopausal symptoms. It has never been approved in the United States by the Food and Drug Administration (FDA) for any indication.

About Cognitive Dysfunction in Multiple Sclerosis

According to the National Multiple Sclerosis Society and the Multiple Sclerosis Society of Canada publication, Hold that Thought! Cognition and MS, it is fairly common for people with multiple sclerosis to complain of problems remembering things, finding the right words, concentrating on a task or something they are reading, or following a conversation. These are all cognitive symptoms of multiple sclerosis. Fifty to sixty-five percent of those affected by multiple sclerosis have cognitive dysfunction. Despite the fact that most symptoms are mild to moderate, they can have a significant impact on a person's ability to normally function. The overall cognitive dysfunction can be described as a reduction in mental "sharpness."

The major areas of cognition that can be dysfunctional include what are termed complex attention and executive functions. Complex attention involves multitasking, the speed with which information can be processed, learning and memory, and perceptual skills; executive functions include problem solving, organizational skills, the ability to plan, and word finding. Just as the nature, frequency, and severity of multiple sclerosis-related physical problems can widely vary, not all people with multiple sclerosis will display these cognitive issues, and no two people will experience exactly the same types or severity of problems.

About Adeona Pharmaceuticals, Inc.

Adeona is a biotechnology company focused on the development of synthetic DNA-based therapeutics and innovative disease-modifying medicines for serious illnesses. Adeona is developing, or has partnered the development of, product candidates to treat pulmonary arterial hypertension, relapses in multiple sclerosis, cognitive dysfunction in multiple sclerosis, fibromyalgia and amyotrophic lateral sclerosis (ALS). For more information, please visit Adeona's website at www.adeonapharma.com.

In December 2011, Adeona announced that the Board of Directors had taken several actions to prioritize the company's focus on its recent entry into the emerging field of synthetic biologics. As a result of its new primary focus, the Board approved a proposed name change of the company to Synthetic Biologics, Inc., to better reflect its new mission and primary business. Such name change is subject to stockholder approval.

Synthetic Biologics is a trademark of Adeona Pharmaceuticals, Inc.

This release includes forward-looking statements on Adeona's current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding the intended enrollment of the Phase II clinical trial for cognitive dysfunction in multiple sclerosis, the potential results of the trial and the funding for the 15-center relapses in multiple sclerosis clinical trial. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Adeona's forward-looking statements include, among others, a failure to complete the intended enrollment, a failure of the clinical trial to provide desired results, our failure to successfully commercialize a new oral therapy for cognitive dysfunction in multiple sclerosis, an inability to complete the trials with the current funding and other factors described in Adeona's report on Form 10-K for the year ended December 31, 2010 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Adeona undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

For further information, please contact Adeona at (734) 332-7800, Ext. 22.

[i] Sicotte, Liva, Klutch, Pfeiffer, Bouvier, Odesa, Wu, Voskuhl, Treatment of multiple sclerosis with the pregnancy hormone estriol, Ann Neurol. 2002 Oct;52(4):421-8.

[ii] Gold and Voskuhl, Estrogen treatment in multiple sclerosis, J Neurol Sci. 2009 Nov 15;286(1-2):99-103. Epub 2009 Jun 18.

 

SOURCE Adeona Pharmaceuticals, Inc.

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